AMITIZA Drug Patent Profile

Which patents cover Amitiza, and what generic alternatives are available?

Amitiza is a drug marketed by Sucampo Pharma Llc and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-two patent family members in nineteen countries.

The generic ingredient in AMITIZA is lubiprostone. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the lubiprostone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Amitiza

A generic version of AMITIZA was approved as lubiprostone by AMNEAL on November 30^th, 2021.

Summary for AMITIZA

International Patents:	72
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	28
Patent Applications:	1,409
Drug Prices:	Drug price information for AMITIZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMITIZA
What excipients (inactive ingredients) are in AMITIZA?	AMITIZA excipients list
DailyMed Link:	AMITIZA at DailyMed

See drug prices for AMITIZA

See drug sales revenues for AMITIZA

Recent Clinical Trials for AMITIZA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sucampo Pharma Americas, LLC	Phase 2
Sucampo AG	Phase 2
Takeda	Phase 2

See all AMITIZA clinical trials

Pharmacology for AMITIZA

Drug Class	Chloride Channel Activator
Mechanism of Action	Chloride Channel Activators

Anatomical Therapeutic Chemical (ATC) Classes for AMITIZA

A06AX	Other drugs for constipation
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for AMITIZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AMITIZA	Capsules	lubiprostone	8 mcg and 24 mcg	021908	1	2012-08-20

US Patents and Regulatory Information for AMITIZA

AMITIZA is protected by six US patents.

Patents protecting AMITIZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	AB	RX	Yes	No
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	AB	RX	Yes	Yes			Y
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008	AB	RX	Yes	No			Y
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006	AB	RX	Yes	Yes			Y

Expired US Patents for AMITIZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-001	Jan 31, 2006
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008
Sucampo Pharma Llc	AMITIZA	lubiprostone	CAPSULE;ORAL	021908-002	Apr 29, 2008

International Patents for AMITIZA

When does loss-of-exclusivity occur for AMITIZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

Israel

Japan

Mexico

New Zealand

Portugal

Russian Federation

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering AMITIZA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2298314	Unité posologique contenant un analogue de prostaglandine permettant de traiter la constipation (Dosage unit comprising a prostaglandin analog for treating constipation)
Mexico	PA04002006	ANALOGOS DE PROSTAGLADINA COMO ABRIDOR DEL CANAL DE CLORURO. (PROSTAGLANDIN ANALOGS AS CHLORIDE CHANNEL OPENER.)
Japan	2004527567
Spain	2309410

Supplementary Protection Certificates for AMITIZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1315485	300757	Netherlands		PRODUCT NAME: LUBIPROSTON; NATIONAL REGISTRATION NO/DATE: RVG 115891; FIRST REGISTRATION NO/DATE: PL21341/0003 20120910
2298314	92826	Luxembourg		PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910
1315485	C01315485/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
1315485	122015000080	Germany		PRODUCT NAME: LUBIPROSTON, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: 92699.00.00 20150519; FIRST REGISTRATION: VEREINIGTES KOENIGREICH PL 21341/0003 20120910